About 20% of pregnant women smoke cigarettes, 12% drink alcohol and 6% use an illicit drug at least once during pregnancy. These numbers are very alarming. If only people knew the dangers of their decisions, perhaps we would be looking at something more acceptable in those numbers.

So what are some of the dangers posed by these substances to a developing fetus?

If Dr. Frances Oldham Kelsey had been named Mary, Helen, or Dorothy, it’s possible that thousands of babies would have died or been born with debilitating birth defects.

In the mid-1930s, after earning a master’s degree in pharmacology in her native Canada, Frances Oldham wrote to Eugene Geiling, a researcher at the University of Chicago, asking to work in his lab and study for a doctorate. Assuming Frances was a man, Dr. Geiling replied with an offer of a scholarship, addressing the letter to “Mr. Oldham.”

Dr. Kelsey upends the stereotype of the government bureaucrat. She saved lives by being a stickler for details.

Reflecting on the incident in an autobiography, she remembered Dr. Geiling as a “very conservative and old-fashioned” man who “did not hold too much with women as scientists.” His assumption that Frances Oldham was male might have played a role in her scholarship and subsequent education, which prepared her for a career that touched every American.

From an Early Victory in Chicago to a New Career in Washington, D.C.

After moving to Chicago, Frances Oldham earned a doctorate in pharmacology in 1938 and a medical degree in 1950. Along the way, she got married, becoming Dr. Frances Oldham Kelsey, and gave birth to two daughters.

Her work in Dr. Geiling’s lab provided early experience in unraveling medical mysteries. In 1937, more than 100 people, including 34 children, died after taking a liquid sulfa drug formulated with an artificial fruit flavor. Dr. Geiling’s team of scientists soon identified the problem: The medicine was composed primarily of antifreeze — along with the active ingredient, coloring, and flavorings. It was sent to market with no testing. Public outrage led to the 1938 passage of the Food, Drug, and Cosmetic Act, which required manufacturers to provide evidence to the FDA that their drugs were safe. Continue reading →